Effect and Safety of Apatinib on Radiation-Induced Brain Injury

NCT04152681 | Unknown Phase 2 DMC

• 1 other identifier: 201910200
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: This early phase 2 clinical trial aims to evaluate the therapeutic effects and safety of apatinib in radiation-induced brain injury. Further study details as provided by Sun Yet-sen Memorial Hospital, Sun Yat-sen University / Yamei Tang. Primary outcome measure: The proportion of patients with an objective response defined as ≥ 25% reduction in brain edema volume on MR fluid attenuated inversion recovery (FLAIR) images.

Conditions

Radiation Injuries

Keywords

Apatinib; Radiation-induced brain injury

Outcome Measures

Primary Outcomes (1)

• Overall efficacy rate

  The proportion of patients with an objective response defined as ≥ 25% reduction in brain edema volume on Magnetic Resonance Imaging (MRI) fluid attenuated inversion recovery (FLAIR) images.

  4 weeks

Secondary Outcomes (6)

• Change of brain necrosis

  4 weeks

• Change in neurological function

  4 weeks

• Change in the quality of life

  4 weeks

• Change of white matter structural connectivity

  4 weeks

• Change in cognitive function

  4 weeks

Study Arms (1)

Assigned Interventions

EXPERIMENTAL

Apatinib with a dosage of 250mg once daily for 4 weeks, in the absence of unacceptable toxicity or severe deterioration.

Drug: Apatinib

Interventions

Apatinib DRUG

Apatinib with a dosage of 250mg once daily for 4 weeks, in the absence of unacceptable toxicity or severe deterioration.

Assigned Interventions

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged ≥35 years;
• Prior radiotherapy for histologically confirmed head and neck cancer ≥12 months prior to study entry;
• Radiographic evidence to support the diagnosis of radiation-induced brain injury without tumor recurrence;
• Estimated life expectancy must be greater than 12 months;
• Routine laboratory studies：Bilirubin ≤ 1.0 × upper limits of normal (ULN)； Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 1.0 × ULN；Creatinine \<1.0 × ULN；White-cell count ≥ 4,000 cells per cubic millimeter；Neutrophils count ≥1500 cells per cubic millimeter；Platelets ≥100,000 cells per cubic millimeter；Hemoglobin ≥110 gram per milliliter；Prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR) within the normal ranges；
• With sufficient cognitive function and language skills for communication and completion of study questionnaires;
• Consent the enrollment of the study.

You may not qualify if:

• Evidence of tumor metastasis, recurrence, or invasion;
• Current usage of bevacizumab;
• Current usage of glucocorticoids;
• Evidence of very high intracranial pressure that suggests brain hernia and the need for surgery;
• History of psychiatric disease before radiotherapy;
• History of seizures;
• History of arteriosclerotic cardiovascular diseases (ASCVD), e.g. stroke, myocardial infarction, and unstable angina, within 6 months;
• Present or previous history of cardiac arrhythmia;
• New York Heart Association Grade II or greater congestive heart failure;
• Significant vascular disease, e.g. moderate or severe carotid stenosis, aortic aneurysm, and history of aortic dissection;
• Severe infection;
• History of allergy to relevant drugs;
• Pregnancy, lactation, or fertility program in the following 12 months;
• History or current diagnosis of peripheral nerve disease;
• Abnormal liver and renal function;

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Yamei Tang

Guanzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Radiation Injuries

Interventions

apatinib

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Yamei Tang, M.D., Ph.D.

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  STUDY DIRECTOR

Central Study Contacts

Yamei Tang, M.D., Ph.D.

CONTACT

86-13556001992; yameitang@hotmail.com

lei He, M.D., Ph.D.

CONTACT

86-13560056821; fallmaple2008@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: November 5, 2019
• Study Start: October 17, 2019
• Primary Completion: February 1, 2020
• Study Completion: March 1, 2020
• Last Updated: November 5, 2019

Record last verified: 2019-11

Locations

CN (1)